AccessGUDID - DEVICE: THD Bandy (08033737712153)

GUDID

Device Identifier (DI) Information

Brand Name: THD Bandy
Version or Model: THD Bandy
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800183
Company Name: THD SPA

Primary DI Number: 08033737712153
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338430324 *Terms of Use

Device Description: THD Bandy is a disposable suction ligator for the treatment of haemorrhoidal disease, ready to use. No cleaning or disinfection required. THD Disposable comes in single packing (single use), including ligator and loading system. THD Bandy connects to a suction system, while it is possible to control the quality of aspirated tissue, around which the elastic band will be released by pulling the trigger

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46878	Haemorrhoid ligation set	A collection of sterile surgical instruments and materials used to locally occlude the blood flow to internal haemorrhoids for their removal. The collection typically includes a ligator preloaded with several ligatures (e.g., latex rubber bands) deployed to the haemorrhoids, an anoscope used to dilate the anus for internal access, and an obturator for insertion of the anoscope. After a ligature has been applied, the haemorrhoid will eventually necrose and pass out of the gut naturally. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FHN	Ligator, Hemorrhoidal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093497	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 154 Millimeter
Outer Diameter: 12.8 Millimeter

Device Record Status

Public Device Record Key: 62aed90d-66b6-46ed-b9e1-f87439f9e813
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 18, 2017